Prospective, multicentric, double-masked clinical study to compare the efficacy and safety of Ganfort and Duotrav in primary open angle and pseudoexfoliative glaucoma patients previously treated with Xalacom

Conditions: Glaucoma
MedDRA version: 9.1Level: LLTClassification code 10037118Term: Pseudoexfoliation glaucoma
MedDRA version: 9.1Level: LLTClassification code 10030348Term: Open angle glaucoma

Registration Number: EUCTR2007-004023-38-DE

Lead Sponsor: GB Bietti Eye Foundation - IRCCS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 124

Inclusion Criteria

1)The patient is suffering from POAG or PEX (If the patient has glaucoma and high IOP in both eyes, both eyes will be treated but the worst eye chose for the statistical analysis). Glaucoma definition is based on the European Glaucoma Society Guidelines.
2)The patient is on either a non-fixed combination of Xalatan and Timolol for at least 3 months or on Xalacom for at least 6 month
3)The patient has an IOP<21 mm Hg at the 8am time point..
4)The patient has not reached the target IOP as set by the treating physician

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Unwilling to sign informed consent
2)Not at least 18 years old
3)Beta blockers are contraindicated
4)Ocular condition that are of safety concern and that can interfere with the study results
5)Closed/barely open anterior chamber angles or history of acute angle closure.
6)Ocular surgery or argon laser trabeculoplasty within the last three months.
7)Ocular inflammation/infection occurring within three months prior to pre-trial visit.
8)Neurovascular Patients (including diabetic patients with neovascular glaucoma)
9)Concominant topical ocular medication that can interfere with study medication
10)Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
11)Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement.
12)Refractive surgery patients
13)Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing.
14)Inability to adhere to treatment/visit plan.
15)Have participated in any other clinical trial (i.e., requiring informed consent) within one to three month prior to pre-trial visit (depending on ethics committee decisions).